BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NEO-PICC

    K Number: K970434 · Decision Apr 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    5
    Review Days
    55

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    Basic Information

    Device Name
    NEO-PICC
    K Number
    K970434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Klein-Baker Medical, Inc.
    Date Received
    February 5, 1997
    Decision Date
    April 1, 1997
    Product Code
    LJS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Klein-Baker Medical, Inc.

    K Number Device Name
    K972731 NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
    K970997 NEO-CARE LUMBER PUNCTURE KIT
    K963972 NEO-CARE DUAL LUMEN UMBILICAL CATHETER
    K963867 NEO-CARE CATHETERIZATION TRAY